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HCT-MDS Medicare Study

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HCT for MDS Medicare Study (CMS)

Patients with Medicare will be eligible for claims coverage from CMS if they participate in this study. View clinical, billing, and reimbursement information below.

Study Title: Assessment of Allogeneic Hematopoietic Stem Cell Transplantation in Medicare Beneficiaries with Myelodysplastic Syndrome and Related disorders - Part I. (10-CMSMDS-1)
Clinical trial number: NCT #01166009, view CIBMTR study plan.
Opened:  December 15, 2010
Study Objectives: 
  • The primary objective of this study is to prospectively examine outcomes of allogeneic HCT in adults >= 65 years of age with MDS to determine whether their outcomes are similar to those in younger patients.
  • To provide a mechanism to Medicare Beneficiaries with MDS for claims coverage for allogeneic HCT.
  • To provide data requested by Medicare under its CED to make payment on claims for HCT using the existing research observational database of the CIBMTR.

 Participating Transplant Center are Required to:

  • Submit Form 2554 (on-demand form) in FormsNet3 for each subject to be enrolled.
  • Complete Form 2400 (Pre-TED) by first selecting the RCI BMT as the study sponsor, and then select from the dropdown "10-CMSMDS-1".
  • Submit Comprehensive Report Forms to CIBMTR for all registered study patients.
 Patient Eligibility:
  • Diagnosis of MDS related disorders, including CMML and therapy-related MDS.
  • Age >= 65 or age <65 and Medicare beneficiary.
  • Willingness to participate and sign informed consent for NMDP/CIBMTR's "Protocol for a Research Database for Hematopoietic Stem Cell Transplantation and Marrow Toxic Injuries (NCT-01166009)"

Consent Forms:

This study uses the existing research observational database of the CIBMTR to collect data requested by CMS as part of its payment policy. Participants who wish to receive coverage from CMS must sign the existing IRB approved standard consent for the research observational database. (See below). Additional protocol or consent forms are not required for this study.

The Research Database protocol and CIBMTR/NMDP IRB approvals, can be found on the Observational Database and Protocol and Consent Forms  page.

Study Contacts:

  • For clinical research questions contact: RaeAnne Besser, CIBMTR-Minneapolis, 763-406-4847 or Cynthia Kunakom, CIBMTR-Minneapolis, 763-406-8285
  • For Medicare claims questions contact: NMDP/Be The Match Payer Policy team,

Coding and Billing:

Medicare has determined allogeneic HCT for MDS to be reasonable and necessary ONLY if provided in a Medicare approved clinical study under Coverage with Evidence Development (CED). 

Transplants are covered in both the inpatient and outpatient hospital setting. Refer to Pub. 100-03, NCD Manual, chapter 1, section 110.8.1, for further information about this policy, and Pub. 100-04, MCP Manual, chapter 32, section 90.6, for information on CED.

For Standard Medicare, Include the Clinical Trial Identifier 

Billing for patients participating in this study with standard Medicare is generally the same as billing Medicare for HCT, except you need to always include the clinical trial identifier on claims.
For inpatient hospital claims with discharge dates on or after August 4, 2010, your Inpatient claims (Type of Bill (TOB) 11X) for HSCT for the treatment of MDS in a clinical study must contain:
  • TOB 11x and:
  •  If ICD-9-CM, diagnoses codes are 238.75 and V70.7
  • If ICD-10-CM, the diagnosis codes are D46.A, D46.B, D46.C,D46.0, D46.1, D46.20, D46.21, D46.22, D46.4, D46.9, or D46.Z, and clinical trial ICD-10-CM diagnosis code Z00.6

To learn more about specific codes to use for this clinical trial, view the Medicare Claims Processing Manual - transplant section 90.3 or a Medicare Matters article (PDF).

For Medicare Advantage, Bill Medicare Directly 

CMS guidance specifies that costs related to a Medicare approved clinical trial, such as the MDS CED, should be paid through traditional fee-for-service Medicare, even when a patient has enrolled in a Medicare Advantage plan. 
When patients have a Medicare Advantage plan, you need to bill Medicare directly, not the Medicare Advantage plan for aspects of care that are related to the clinical trial.  
In the case of the MDS study, this includes the transplant hospitalization and any associated follow-up care or hospitalizations attributable to the transplant. This would apply for as long as care is provided that is related to the original transplant for MDS. Centers are asked to treat this on a patient-by-patient basis and use their clinical judgment and integrity in discerning which claims are transplant associated. All such claims should be marked with the 8 digit clinical trial number: NCT #01166009. See Section L of the attached reference: 2011 Combined Call Letter for more information about Medicare Advantage plans and clinical trials administration. 
To learn more, view clarifications from CMS with regard to billing for patients on the study with a MedicareAdvantage plan (

For Post-Transplant Care, Include Clinical Trial Number 

CMS clarified that all traditional FFS Medicare beneficiaries should also have their transplant-associated subsequent care and hospitalizations marked with the clinical trial number. The length of time during which subsequent care is related to the transplant will vary by patient and is up to the medical determination of the provider. This will not affect reimbursement; it is for tracking purposes only. 
Remember that proper documentation of subsequent admissions or care and attribution of association with transplantation is very important as these claims are subject to the usual auditing practices.  


If you receive a denial notice for a patient in the MDS study, the best initial course of action is to work with your local Medicare contractor to understand the reason for the denial and the possible course of action or appeal.
If the issue is something that cannot be resolved in this manner or is in relation to what your center believes to be a misinterpretation of the Coverage with Evidence Determination guidelines, please contact NMDP/Be The Match Payer Policy team,

Study Reference Materials:

Last Updated: 2/28/2017 11:34 AM